Advancing Standards for Clinical Diagnostics
March 23, 2017, at 12:00 PM ETAbstract
Assay consistency and standardization are essential for providing the best patient care. To help promote the generation of reliable and reproducible data, the use of authenticated, well-characterized standards are needed throughout assay development, validation, and implementation. In this webinar, we will discuss the need for standards in clinical laboratory testing, and we will expand on how ATCC supports this with authenticated biological and molecular reference materials.
Key Points
- There is a recognized need for established, fully characterized, globally accepted reference materials
- Standards can be used to benchmark critical assay performance during development, validation, and implementation
- ATCC supports scientific research and breakthroughs through the continual development of authenticated standards and reference materials
Presenter
Maryellen de Mars, PhD
Senior Director of Standards Resource Center, ATCC
Maryellen de Mars, Ph.D., is the Senior Director of the Standards Resource Center at ATCC. She has over 25 years of experience in development of biological research tools, services and standards. Dr. de Mars has a Ph.D. in Virology from the University of Texas Health Science Center at Houston and completed a post-doctoral fellowship in molecular biology at Johns Hopkins University.
Questions and Answers
Does ATCC have a service for authenticating cell lines?
ATCC offers complete cell line authentication services utilizing Short Tandem Repeat (STR) profiling. STR profiling helps to detect misidentified, cross-contaminated, or genetically drifted cells, which invalidate research results. ATCC’s STR report meets all requirements for funding, publication, and quality control. Here, we perform a PCR assay and create the corresponding STR profile for your human cell line that is then compared our human cell line database. We then develop a profile comparison report for your cell line in a PDF format and send it you through email. In addition to STR profiling, we also provide mycoplasma testing using a bundled approach of direct and indirect culture, or using the PCR method. We use the PCR-based Universal Mycoplasma Detection Kit (UMDK) (ATCC 30-1012K) for detecting over 60 species of Mycoplasma, Acholeplasma, Spiroplasma, and Ureaplasma, including the eight species most likely to afflict cell cultures. We are also currently working with NIST to further develop the mouse STR technology for inclusion in our services business.
What will the next ANSI/ATCC consensus standard be on?
The next consensus standard in development is ASN-0004 Species-Level Identification and Cross-Contamination Screening in Animal Cells by Multiplex PCR. This standard covers a recommended procedure for species-level identification and cross-contamination screening that balances the need for testing rigor, while keeping speed and cost efficiency at the forefront. Traditionally, isoenzymological identification methods have been useful for species identification in cell culture, but the reagents for this method are no longer commercially available. In its place, we are recommending and developing a standard for a multiplex PCR-based approach. More information is available at the ANSI eStandards Store.
Will there be a consensus standard on the standardization of STR profiling for the authentication of mouse cell lines?
Currently the plan is that once the mouse STR technology is fully developed through the ATCC/NIST collaboration in conjunction with the Mouse STR Consortium, a consensus standard will be developed for using STR profiling for mouse cells through the ATCC Standards Development Organization. Read more about the Mouse Cell Line Authentication Consortium, and watch the recorded webinar.
Can you provide more information what types of reference materials ATCC has available?
ATCC provides reference materials as catalogue products or through custom solutions. Over 475 cell lines, microbes, or derivatives sold as products are currently recognized as standards by external organizations such as FDA or USP. For those requiring custom solutions, we can work to provide our catalogue material (cell lines and microbes) in custom volumes, formats (e.g. spike-ins, FFPE), or specialized configurations and packaging for specific platforms or instruments. For those requiring custom solutions, we can work to provide our catalogue material (cell lines and microbes) in custom volumes, formats (e.g. spike-ins, FFPE), or specialized configurations and packaging for specific platforms or instruments.
